COMPLETED

Long-acting Naltrexone for Pre-release Prisoners

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.

Official Title

Long-acting Naltrexone for Pre-release Prisoners: A Randomized Trial of Mobile Treatment

Quick Facts

Study Start:2017-01-01

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT02867124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days * History of opiate disorder \[meeting DSM-V criteria of dependence at the time of incarceration\] * Suitability for XR-NTX treatment as determined by medical evaluation * Currently opioid-free by history, with negative urine for all opioids and no signs of opiate withdrawal * Willingness to enroll in XR-NTX treatment in prison \[not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release\] * Planning to live in Baltimore City or County. * Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration	* Liver function test levels greater than three times normal * Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease). Adequately treated medical conditions are acceptable * Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania). Adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed * History of allergic reaction to XR-NTX * Current chronic pain diagnosis for which opioids are prescribed * Creatinine above normal limits * Pregnancy (for women) * Breast-feeding (for women) * Suicidal ideation (within the past 6-months) * Body Mass Index (BMI) \> 40 * Unadjudicated charges that may result in transfer to another facility and/or additional prison time.

Inclusion Criteria

Exclusion Criteria

* Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days
* History of opiate disorder \[meeting DSM-V criteria of dependence at the time of incarceration\]
* Suitability for XR-NTX treatment as determined by medical evaluation
* Currently opioid-free by history, with negative urine for all opioids and no signs of opiate withdrawal
* Willingness to enroll in XR-NTX treatment in prison \[not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release\]
* Planning to live in Baltimore City or County.
* Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration

* Liver function test levels greater than three times normal
* Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease). Adequately treated medical conditions are acceptable
* Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania). Adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed
* History of allergic reaction to XR-NTX
* Current chronic pain diagnosis for which opioids are prescribed
* Creatinine above normal limits
* Pregnancy (for women)
* Breast-feeding (for women)
* Suicidal ideation (within the past 6-months)
* Body Mass Index (BMI) \> 40
* Unadjudicated charges that may result in transfer to another facility and/or additional prison time.

Contacts and Locations

Principal Investigator

Michael S Gordon, DPA

PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Study Locations (Sites)

Maryland Department of Public Safety and Correctional Services

Towson, Maryland, 21286

United States

Collaborators and Investigators

Sponsor: Friends Research Institute, Inc.

Michael S Gordon, DPA, PRINCIPAL_INVESTIGATOR, Friends Research Institute, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-01-01

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2017-01-01

Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

Opiate Addiction